Class I · High risk
HCG (Lyophilized)
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
FDA Drug Recalls
112 recalls · Class I, newest first
Class I · High risk
Affirm XL Nutritional Supplement
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Class I · High risk
ROCK-IT MAN capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Class I · High risk
Piperacillin and Tazobactam for Injection
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Class I · High risk
Magnesium Sulfate 2 grams in Dextrose 5% for Injection
Non-Sterility; mold contamination
Class I · High risk
Night Bullet Capsules
Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
Class I · High risk
MAXILOSS Weight Advanced
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Class I · High risk
Vistide (cidofovir)
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Class I · High risk
Reumofan Plus
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Class I · High risk
Mitosol (mitomycin for solution)
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.